In drug development, success often hinges on a deceptively simple question: how will the body respond? For Dr. Kidochukwu ...
The startup has partnered with Eli Lilly and enjoys the backing of some of Silicon Valley's most influential VCs.
J&J, having already announced several manufacturing investments in North Carolina, has announced another one: a new drug ...
To address rising threat of antimicrobial resistance, India’s drug regulator plans an overhaul of regulations for antibiotics ...
Please provide your email address to receive an email when new articles are posted on . AIM-MASH AI Assist is the first AI drug development tool to be qualified by the FDA. The tool is designed to ...
In the final part of his Pharma Commerce video interview, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, previews his December column, ...
The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...
Two formative experiences shaped Craig Crews’ path into drug development. First, when he was still a child, his grandmother died from cancer at just 52 years old. “At the time, there weren’t very many ...
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the ...
1 School of BioSciences, Faculty of Science, University of Melbourne, Parkville, VIC, Australia 2 School of Stomatology, Shandong Second Medical University, Weifang, China Oral diseases, including ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, MD, and CMS Administrator Mehmet Oz, MD, announced new FDA guidance aimed at making biosimilar drug development faster and less ...
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